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Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 1 Diabetes Mellitus

Intervention: Ethanol (Drug); Xeris Glucagon (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Steven J Russell, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Mallory A Hillard, BS, Phone: 617-643-2019, Email: MAHILLARD@MGH.HARVARD.EDU

Summary

This study will test the hypothesis that a BAC (blood alcohol content) of 0. 1% will not significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with type 1 diabetes.

Clinical Details

Official title: Effect of Ethanol Intoxication on the Anti-hypoglycemic Action of Glucagon

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: AOCGIR (Area Over the Curve for Glucose Infusion Rate)

Secondary outcome: Maximum Change in GIR (Glucose Infusion Rate)

Detailed description: This study will test the hypothesis that a BAC (blood alcohol content) of 0. 1% will not significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with type 1 diabetes. The study will aim to quantify the effect of a blood alcohol content on the

anti-hypoglycemic efficacy of glucagon using a hyperinsulinemic - normoglycemic clamp

technique in volunteers with type 1 diabetes in a randomized crossover trial.

Eligibility

Minimum age: 21 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

- Inclusion Criteria:

- Age 21 to 80 years old with type 1 diabetes for at least one year.

- Diabetes managed using an insulin infusion pump using rapid-acting insulin such

as insulin aspart (NovoLog), insulin lispro (Humalog), or insulin glulisine (Apidra) for at least one week prior to enrollment.

- Alcohol exposure on at least one occasion in the last year consisting of at

least 4 drinks in one sitting.

- Exclusion Criteria:

- Unable to provide informed consent.

- Unable to comply with study procedures.

- Unable to refrain from the consumption of alcohol at least 24 hours prior to

study start.

- Current participation in another diabetes-related clinical trial that, in the

judgment of the principle investigator, will compromise the results of the clamp study or the safety of the subject.

- Pregnancy (positive urine HCG), breast feeding, plan to become pregnant in the

immediate future, or sexually active without use of contraception.

- Aldehyde dehydrogenase deficiency as determined by a screening questionnaire

- End stage renal disease on dialysis (hemodialysis or peritoneal dialysis).

- History of pheochromocytoma (because glucagon has been reported to precipitate

hypertensive crisis in the setting of pheochromocytoma). Fractionated metanephrines will be tested in patients with a history increasing the risk for a catecholamine secreting tumor:

- Paroxysms of tachycardia, pallor, or headache. Personal or family history of

MEN 2A, MEN 2B, neurofibromatosis, or von Hippel-Lindau disease, Episodic or treatment of refractory (requiring 4 or more medications to achieve normotension) hypertension.

- History of adverse reaction to glucagon (including allergy) besides nausea,

vomiting, or headache.

- Inadequate venous access as determined by study nurse or physician at time of

screening.

- Liver failure or cirrhosis

- Hemoglobin < 12 gm/dl.

- History of problem drinking or alcoholism, regardless of whether active or in

remission.

- Use of benzodiazepines or barbiturates or opiates or other central nervous

system depressant drugs that could act synergistically with ethanol to lower the level of consciousness

- Any other factors that, in the judgment of the principal investigator, would

interfere with the safe completion of the study procedures.

Locations and Contacts

Mallory A Hillard, BS, Phone: 617-643-2019, Email: MAHILLARD@MGH.HARVARD.EDU

Massachusetts General Hospital Diabetes Research Center, Boston, Massachusetts 02114, United States
Additional Information

Starting date: August 2015
Last updated: August 3, 2015

Page last updated: August 23, 2015

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